At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Test +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Single-dose, 2-way Crossover, Open-label, Comparative Bioavailability Study Comparing Test Naproxen Sodium Tablets (2 x 220 mg) With Commercially Available Reference Naproxen Sodium Tablets (2 x 220 mg) in the Fasted State
In Brief
A Phase 1 clinical trial evaluating Test and Reference for Healthy. Completed, enrolled 18 participants.
Detailed Summary
This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands in order to support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
CollaboratorsSimbec Research
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartOct 2016
Primary CompletionDec 2016
First PostedMay 2017
TodayJul 2026
First PostedMay 30, 2017
Enrollment StartOct 12, 2016
Primary CompletionDec 2, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.1 years ago
Interventions
Testdrug
RB naproxen sodium tablets (2x220mg)
Referencedrug
Aleve naproxen sodium tablets (2x220mg)